MAUDE Adverse Event Report: COVIDIEN LP MARYLAND JAW LAP (37CM); LIGASURE VESSEL SEALING SYSTEM

Model Number LF1737

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The incident sample has been requested but to date has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported that during surgery on a living donor kidney, sealing was not completed even though an end tone, indicating a completed seal cycle was heard.The vessel appeared to be sealed but opened later during the procedure.Patient experienced blood loss of approximately 500ccc's but no transfusion was required.No other patient injury or tissue damage was reported.Procedure was completed without further complication.

• Brand Name: MARYLAND JAW LAP (37CM)
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer (Section G): BOULDER
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5254255
• MDR Text Key: 32291800
• Report Number: 1717344-2015-00852
• Device Sequence Number: 1
• Product Code: BWA
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LF1737
• Device Catalogue Number: LF1737
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other